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18F-FLT-PET/CT Imaging · 1 trial · 1 indication
Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmean averages the radioactivity values within a region of interest.
Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of tissue radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmax measures the maximum radioactivity values within a region of interest.
Core needle biopsies (CNB) are obtained after completing imaging studies at baseline and approximately 2 to 3 weeks later, after the first cycle of chemotherapy. These tissue samples are then used to measure expression of the cell proliferation marker Ki-67, by manually counting percentage positive immunostained cells, denoted the labeling index (LI).
The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
| Arm | Type | Description |
|---|---|---|
| All Participants | EXPERIMENTAL | 18F-FLT-PET imaging |
| Name | Type | Description |
|---|---|---|
| 18F-FLT-PET/CT Imaging | RADIATION | Participants receive the investigational radiotracer 18F-FLT intravenously and undergo Positron Emission Tomography (PET)/Computed Tomography (CT) scans at the following three times: prior to initiation of chemotherapy, at the end of the first cycle of treatment, and at the conclusion of chemotherapy. |
Inclusion Criteria: * Has newly-diagnosed stage IIB/IIIA/IIIB locally advanced breast cancer * Is eligible for pre-operative (neo-adjuvant) chemotherapy Exclusion Criteria: * Has a contraindication to magnetic resonance imaging (MRI) * Any condition that would limit ability to undergo MRI or PET ...
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18F-FLT-PET/CT Imaging is an investigational imaging technique being studied for use in breast cancer. It is a positron emission tomography (PET) imaging method that uses a radioactive tracer called 18F-FLT to visualize cellular proliferation. The imaging is being evaluated in a clinical trial to assess its potential role in breast cancer.
18F-FLT-PET/CT Imaging is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research to evaluate this imaging technique in the context of breast cancer.
18F-FLT-PET/CT Imaging is in Phase 2 clinical development. It is an investigational imaging agent and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the imaging technique remains under investigation for its potential use in breast cancer.
18F-FLT-PET/CT Imaging has been studied in one completed clinical trial, identified as NCT01015131, titled '18F-FLT-PET in Breast Cancer (MK-0000-139)'. This Phase 2 trial enrolled 46 female participants aged 35 years and older with breast cancer. The trial was uncontrolled and not randomized or double-blinded.
18F-FLT-PET/CT Imaging is not FDA approved. It is an investigational imaging technique currently in clinical development. The completed Phase 2 trial (NCT01015131) evaluated its use in breast cancer, but regulatory approval has not been granted. The imaging agent remains under investigation.